Endpoints - Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles





   

GBI Research in its report “Endpoints- Clinical Trials in Respiratory Diseases - Pulmonary Function Tests, Biomarkers and Quality of Life Questionnaires All Play Prominent Roles” presents the use of endpoints or outcomes measures in respiratory disease’s clinical trials. In this report, endpoint used in asthma, cystic fibrosis, chronic obstructive pulmonary disorder and pulmonary arterial hypertension are presented. In this report detailed analysis about the clinical and surrogate endpoint used in various phases and stages of clinical trials are presented. This report presents detailed overview about the endpoint used in major marketed drugs and most promising molecules under development. The report contains company profiles of major companies involved with marketing of major marketed drugs under respiratory drug franchise.   

     

Scope

   

  • The report starts with an executive summary, providing insights about the prominent endpoint used in respiratory clinical trials.   
  • This report deals with different types of endpoint used in respiratory clinical trials. It contains brief account of advantages, disadvantages and regulatory aspects of each type of endpoint.   
  • This report provides in-depth analysis of clinical trial endpoints used in asthma, COPD, cystic fibrosis and PAH clinical trials.   
  • This report covers complete account of primary and secondary endpoints used in Phase III and Phase II clinical trials in above mentioned respiratory diseases.   
  • In this report characterization and segmentation of trials based on their status, along with specific use of endpoints is also provided.   
  • This report provides profiling of major marketed drugs based on their safety, efficacy and clinical study details.   
  • The report contains company profiling of major companies associated with marketing of major respiratory drugs covering asthma, COPD, cystic fibrosis and PAH.   
  • This report also includes endpoint analysis of terminated trials for asthma, COPD, cystic fibrosis and PAH. Analysis of terminated trials can be used in designing more robust trials and avoid any issues, which can result in termination of trial.  

 

  

  

Reasons to Buy

   

  • Understand the pattern of use of primary and secondary endpoints, according to specific indication’s and clinical Phase of trial. This will help in designing clinical trials so as to and protect one’s product from confronting any of the safety issues.   
  • To analyze the major primary and secondary endpoint used in disease specific clinical trials.   
  • Reinforce R&D strategies by identifying new endpoints to be used in disease and clinical phase specific clinical trials. This can increase positive outcome from a trial and aid in bringing molecules with increased efficiency and better safety profiles.   
  • Develop key strategic initiatives by understanding the key focus of major companies developing drugs in respiratory franchise.   
  • Build effective strategies by clinical phase wise endpoint analysis of clinical trials. This can help in reducing the drug’s time to market.   
  • Exploit strategies for designing of clinical trials by identifying the advantages and disadvantages involved with the use of specific endpoints.   

 

   

 

  

 1 Table of Contents 
1.1 List of Tables 
1.2 List of Figures 
 
2 Introduction 
 
3 Clinical Trials Endpoints in Respiratory Diseases - An Overview 
3.1 Introduction 
3.2 Types of Endpoints 
3.2.1 Primary Endpoints 
3.2.2 Secondary Endpoints 
3.2.3 Surrogate Endpoints 
 
4 Endpoints - Clinical Trials in Asthma - Marketed and Pipeline Products Assessment 
4.1 Introduction 
4.2 Primary Endpoints Used in Asthma Clinical Trials 
4.2.1 Pulmonary Function Tests: 
4.2.2 Vital Signs and Physical Activity 
4.2.3 Biomarkers 
4.2.4 Serious Adverse Events 
4.3 Secondary Endpoints Used in Asthma Clinical Trials 
4.3.1 Pharmacokinetics and Pharmacodynamics 
4.3.2 Quality of Life Scores 
4.3.3 Clinical Laboratory Tests – Biochemistry and Serum Hematology 
4.3.4 Use of Rescue Medication 
4.4 Asthma Therapeutics – Major Marketed Drugs 
4.4.1 Singulair (Montekeulast Sodium) 
4.4.2 Accolate Accoleit, Vanticon (Zafirlukast) 
4.4.3 Zyflo (Zileuton) 
4.4.4 Foradil (Formoterol Fumarate Inhalation Powder) 
4.4.5 Symbicort (budesonide/formoterol fumarate dihydrate inhalation aerosol) 
4.4.6 Xolair (Omalizumab) 
4.4.7 Serevent Diskus (Salmaterol Xinafoate Inhalation Powder) 
4.4.8 Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) 
4.5 Asthma Therapeutics – Promising Drugs under Clinical Development 
4.5.1 Daxas (Roflumilast) (Daxas, APTA 2217, B9302-107, BY 217, BYK 20869) 
4.6 Phase III Clinical Trial Analysis 
4.6.1 Completed Trial Analysis 
4.6.2 Active Trial Analysis 
4.6.3 Terminated Trial Analysis 
4.7 Phase II Clinical Trial Analysis 
4.7.1 Completed Trial Analysis 
4.7.2 Active Trial Analysis 
4.7.3 Terminated Trial Analysis 
 
5 Endpoints - Clinical Trials in Chronic Obstructive Pulmonary Disorder - Marketed and Pipeline Products Assessment 
5.1 Introduction 
5.2 Primary Endpoints Used in COPD Clinical Trials 
5.2.1 Pulmonary Function Tests 
5.2.2 Baseline Dyspnea Index and Borg-Dyspnea Score 
5.2.3 Rate of Exacerbations 
5.2.4 Induced Sputum Analysis 
5.2.5 Biomarkers of COPD 
5.3 Secondary Endpoints Used in COPD Clinical Trials 
5.3.1 Exercise Endurance Time 
5.3.2 Serum Hematology 
5.3.3 Six Minute Walk Distance 
5.3.4 Time to First Exacerbation 
5.4 COPD Therapeutics – Major Marketed Drugs 
5.4.1 Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) 
5.4.2 Brovana (Arformoterol) 
5.4.3 Foradil Aerolizer (Formoterol Fumarate Inhalation Powder) 
5.4.4 Symbicort (Budesonide/Formoterol Fumarate Dihydrate) 
5.4.5 Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder) 
5.4.6 Daxas (roflumilast) 
5.5 COPD Therapeutics – Promising Drugs Under Clinical Development 
5.5.1 Aclidinium Bromide 
5.5.2 NVA237 (Glycopyrronium Bromide) 
5.5.3 Dulera 
5.6 Phase III Clinical Trial Analysis 
5.6.1 Completed Trial Analysis 
5.6.2 Active Trials Analysis 
5.6.3 Terminated Trial Analysis 
2. Efficacy and Safety endpoints refer to those trial endpoints where the specific details about the endpoints were not disclosed by the trial sponsors or on the Clinicaltrials.gov website 
5.7 Phase II Clinical Trial Analysis 
5.7.1 Completed Trial Analysis 
5.7.2 Active Trial Analysis 
5.7.3 Terminated Trial Analysis 
 
6 Endpoints - Clinical Trials in Cystic Fibrosis - Marketed and Pipeline Products Assessment 
6.1 Introduction 
6.2 Primary Endpoints Used in Cystic Fibrosis Clinical Trials 
6.2.1 Coefficient of Fat Absorption 
6.2.2 Lung Microbiology 
6.2.3 Biomarkers 
6.3 Secondary Endpoints Used in Cystic Fibrosis Clinical Trials 
6.3.1 Nasal Potential Difference 
6.3.2 Sweat Chloride Concentration 
6.4 Cystic Fibrosis Therapeutics – Major Marketed Drugs 
6.4.1 Tobi (Tobramycin Inhalation Solution) 
6.4.2 Pulmozyme (Dornase Alfa) 
6.4.3 Cayston (aztreonam for Inhalation Solution) 
6.4.4 Colistimethate sodium (Colistin, Colomycin Injection, Promixin, Coly-Mycin M) 
6.5 Cystic Fibrosis – Promising Drugs Under Clinical Development 
6.5.1 Denufosol Tetrasodium Inhalation Solution (INS37217) 
6.5.2 VX-770 
6.5.3 Bronchitol 
6.5.4 Ataluren (PTC-124) 
6.6 Phase III – Clinical Trial Analysis 
6.6.1 Completed Trial Analysis 
6.6.2 Active Trial Analysis 
6.6.3 Terminated Trial Analysis 
6.7 Phase II – Clinical Trial Analysis 
6.7.1 Completed Trial Analysis 
6.7.2 Active Trial Analysis 
6.7.3 Terminated Trial Analysis 
 
7 Endpoints - Clinical Trials in Pulmonary Arterial Hypertension - Marketed and Pipeline Products Assessment 
7.1 Introduction 
7.1.1 Classification of Pulmonary Hypertension 
7.2 Primary Endpoints Used in Pulmonary Hypertension Trials 
7.2.1 Cardiopulmonary Hemodynamic Test 
7.2.2 Six Minutes Walking Distance 
7.2.3 Biomarkers 
7.3 Secondary Endpoints Used in Pulmonary Hypertension Trials 
7.3.1 Time to Clinical Worsening 
7.3.2 SF-36 Health Survey 
7.4 Pulmonary Arterial Hypertension – Major Marketed Drugs 
7.4.1 Tracleer 
7.4.2 Remodulin 
7.4.3 Revatio 
7.4.4 Ventavis 
7.4.5 Letairis 
7.4.6 Adcirca 
7.5 Pulmonary Arterial Hypertension – Promising Drugs under Clinical Development 
7.5.1 ACT-064992 
7.5.2 Oral Treprostinil 
7.5.3 ACT-293987 
7.5.4 Riociguat (BAY63-2521) 
7.6 Phase III Clinical Trial Analysis 
7.6.1 Completed Trial Analysis 
7.6.2 Active Trial Analysis 
7.6.3 Terminated Trial Analysis 
7.7 Phase II Clinical Trial Analysis 
7.7.1 Completed Trial Analysis 
7.7.2 Active Trial Analysis 
7.7.3 Terminated Trial Analysis 
 
8 Endpoints - Clinical Trials in Respiratory Diseases - Company Profiling 
8.1 GlaxoSmithKline Plc 
8.1.1 Overview 
8.1.2 Respiratory Disease Portfolio 
8.2 AstraZeneca 
8.2.1 Overview 
8.2.2 Respiratory Disease Portfolio 
8.3 F.Hoffmann La Roche 
8.3.1 Overview 
8.3.2 Respiratory Disease Portfolio 
8.4 Merck & Co Inc 
8.4.1 Overview 
8.4.2 Respiratory Disease Portfolio 
8.5 Novartis AG 
8.5.1 Overview 
8.5.2 Respiratory Disease Portfolio 
8.6 Boehringer Ingelheim GmbH 
8.6.1 Overview 
8.6.2 Respiratory Disease Portfolio 
 
9 Clinical Trials Endpoints in Respiratory Therapeutics - Appendix 
9.1 Market Definitions 
9.2 Abbreviations 
9.3 Sources 
9.4 Research Methodology 
9.4.1 Clinical Trial Design Overview 
9.4.2 Top Four Indications in Respiratory Therapy Area and their Product Profiling 
9.4.3 Marketed and Pipeline Products Assessment 
9.4.4 Company Profiling 
9.4.5 Expert Panel Validation 
9.5 Contact Us 
9.6 Disclaimer